M00022577
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 33: GUIDANCE ON TESTS TO EVALUATE GENOTOXICITY - SUPPLEMENT TO ISO 10993-3
International Organization for Standardization
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Availability date: 11/05/2021
Foreword
Introduction
1 Scope
2 Selection of tests
3 Recommended tests
4 Use of in vitro tests to detect genotoxicity
5 Use of in vivo tests to detect genotoxicity
6 Bacterial reverse mutation assay
7 In vitro mammalian chromosome aberration test
8 In vitro mammalian micronucleus test
9 In vitro mammalian cell gene mutation test using
mouse lymphoma (L5178Y) cells
10 In vivo mammalian erythrocyte micronucleus test
11 Chromosome aberration test (in vivo)
Bibliography
Describes the views of regulatory bodies on the subject of genotoxicity testing.
Published | |
Document Type | Standard |
Status | Current |
Publisher | International Organization for Standardization |
Pages | |
ISBN | |
Committee | TC 194 |